The purpose of this study is to see if treatment with sodium bicarbonate will lower urine levels of proteins that are indicators of kidney damage in people with diabetes who also have chronic kidney disease.

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:

Change in urinary transforming growth factor beta 1 (TGF-b1) [ Time Frame: The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value. ] [ Designated as safety issue: No ]

Urinary TGF-b1 is considered a marker of renal fibrosis

Secondary Outcome Measures:

Change in urinary Bb and membrane attack complex (MAC) [ Time Frame: The mean of the 3-month and 6-month urinary Bb and MAC measurements will be compared to the baseline values. ] [ Designated as safety issue: No ]

Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.

Placebo Comparator: Arm 2

Placebo

Drug: Placebo

Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.

Detailed Description:

Diabetic chronic kidney disease (CKD) is a common problem in Veterans and progresses to end-stage renal disease in many people. It is important to identify treatment strategies that will help prevent the progression of CKD to overt kidney failure. The purpose of this study is to see if sodium bicarbonate reduces urinary markers of kidney damage in Veterans with diabetic CKD and normal serum bicarbonate levels.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Veteran

Age older than 18 years

Diabetes mellitus

Serum bicarbonate 22 - 28 mmol/L on the most recent measurement within the past six months

Significant fluid overload such that it is unsafe in the opinion of the PI for the patient to participate in the trial

chronic gastrointestinal disorder or any other factors judged to be likely to limit adherence to interventions (i.e. alcoholism, a history of missing clinic visits)

Chronic immunosuppressive therapy for transplanted organs or other indications

Individuals who are currently a member of a vulnerable population (I.e. incarcerated, pregnant).

11.Currently participating in another interventional research study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574157